Sunil Jain: Patent power

RATIONAL EXPECTATIONS

While the number of Indians reading foreign newspapers is limited, and those going beyond the headlines into the editorial columns an even smaller fraction, it's interesting to see how bad news continues to get picked up very fast.

So, when The New York Times ran an editorial on January 18 lambasting India for tilting in favour of large pharmaceutical firms while formulating the new patents regime, it went around the email circuits rapidly and also found its way into newspaper columns in the country.

A former colleague had a large story extensively quoting from the editorial, even endorsing the view that when the ordinance has to be ratified, Parliament should change it since according to the NYT it "does not even take advantage of rights countries enjoy under the WTO to protect public health".

My view is the NYT's got it wrong since issues like low-priced drugs are effectively dealt with. For this column, however, let's ignore the benefits of the ordinance in terms of what it will do to spur R&D since Indian firms will now be able to get their discoveries patented and therefore the benefits to Indian patients will be significant""do you know that there hasn't been a new drug for diseases like TB for more than 25 years now and for over 40 in the case of malaria?

These are not diseases and therefore drugs that interest western pharmaceutical firms and so far Indian firms haven't bothered to develop new cures either since there was no great money to be made out of them (thanks to the DPCO, which controlled prices for medicines) and in any case any new drug would be copied by others in the absence of patent protection.

The first issue NYT deals with is that while countries such as Malawi can get anti-AIDS copycat drugs from India which cut down the price of anti-retroviral therapy from $12,000 a year to around $140, this will not be allowed anymore since "getting a compulsory licence would be slow and difficult; each application would face a fight from multinational drug firms and the governments that do their bidding".

Apart from the fact that it isn't very nice, or correct, to be labelled a country which does the bidding of MNCs, under the Doha declaration, which dealt with issues of low-cost drugs, it is Malawi that needs to issue a "compulsory licence" which allows legal copying of an existing patented drug.

Clause 54 of The Patents (Amendment) Ordinance, 2004, says "compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country".

What of us? How do we ensure new drugs are available at what we determine to be a reasonable price? The Patents (Amendment) Act, 2002, deals with this, and the 2004 ordinance leaves this unchanged.

One of the clauses dealing with this says compulsory licences will be triggered by various criteria as general as "the reasonable requirements of the public with respect to the patented invention have not been satisfied" or "the patented invention is not available to the public at a reasonably affordable price".

The 2002 Act in fact may be overly generous on "compulsory licence" since it allows for this if even "a market for export of the patented article manufactured in India is not being supplied or developed"""in one case I was told of, a host of firms in India made grounds for a "compulsory licence" for producing Viagra for export to Virgin Islands arguing the patent holder was not supplying its wonder cure to this market!

Needless to say the Viagra export orders allegedly emanating from Virgin Islands were several hundred times higher than those required to service the needs of Virgin Islands' residents over their lifetime.

There is then the issue of "evergreening" of patents the NYT talks of, or the policy to keep patents alive forever by finding new uses for existing drugs and then applying for a new patent (like Viagra being used for curing erectile dysfunction after it was discovered as a cure for heart problems), or by even by changing doses of the drug (such as a once-a-day ciprofloxacin dose with a controlled release mechanism as compared to a conventional twice-or-thrice daily drug).

The 2002 Act doesn't allow this and says a patent will be granted only to a "new product or process involving an inventive step and (is) capable of industrial application".

The reason this is hitting big pharma is that I've been given presentations by an MNC on how the concept of patents remains restrictive under the ordinance, and how Indian firms themselves are applying for dosage-change type patents in global markets.

Indeed, with all patent offices in the process of getting linked online and the patent examination process getting faster (with six times as many examiners today the entire mailbox of applications will be ready for publication within five months), the new regime's already looking good""indeed, the timelines for examining patents and filing opposition to them have also been streamlined.

From the point of view of those, like myself, who felt India's traditional knowledge base would get patented abroad (such as the limited exercise with neem), the good news is that the traditional knowledge base that CSIR chief Dr R A Mashelkar was asked to develop in the late 1990s already has 1.8 lakh records, of which 1.3 lakh have already been digitised.

So, the next time someone in the US tries to patent the use of adrak (ginger) and honey to cure a common cold, for instance, he'll be told to go take a hike since it will be present in our database.

Postscript: I'm glad we're reading foreign newspapers a lot more closely now, but let's not take their word as the gospel.